Paracetamol/ Salicylamide/ Ascorbic Acid/ Caffeine/ Chlorphenamine/ Phenylephrine

Registered South African indications:

• Relief of symptoms associated with colds and influenza such as nasal congestion, headache, minor aches and pains
• Relief of cold symptoms, sinus congestion, hayfever

Registered South African contraindications

100/75/50/30/2/2 (mg) capsule

• Hypersensitivity to active ingredients or to any of the excipients in this combination product
• Hypertension
• Cardiovascular disease
• Hyperthyroidism
• Pregnancy
• Severe liver function impairment
• Children under six years of age
• Persons being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment

125/150/100/30/2/2 (mg) capsule

• Hypersensitivity to active ingredients or to any of the excipients in this combination product
• Impaired kidney function
• Impaired liver function
• Acute porphyria
• Pregnancy
• Breastfeeding

As the formulation contains salicylamide and caffeine the following are contraindications:

• Gastric ulceration or hyperacidity

As the formulation contains salicylamide the following are contraindications:

• Haemorrhagic disorders and haemophilia

As the formulation contains chlorphenamine the following are contraindications:

• Acute attacks of asthma
• Prostatic hypertrophy

As the formulation contains phenylephrine the following are contraindications:

• Hyperthyroidism
• Diabetes mellitus
• Closed angle glaucoma
• Cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia
• Occlusive vascular disorders, including arteriosclerosis
• Hypertension
• Aneurysms
• Patients being treated with a monoamine oxidase inhibitor or within 14 days of stopping such treatment

South African recommendations

• Breastfeeding (100/75/50/30/2/2 (mg) capsule)
• Renal impairment (100/75/50/30/2/2 (mg) capsule)
• Mild to moderate hepatic impairment (100/75/50/30/2/2 (mg) capsule)
• Elderly

Excessive dosage

• Avoid usage beyond the recommended dose
• Do not use continuously for more than 10 days without consultation

Liver disease patients

• Consult medical supervision before using paracetamol
• Caution when using other liver-affecting medicines with this combination agent

Alcohol & CNS depressants

• Avoid simultaneous intake of alcohol and CNS depressants with this combination agent due to potential drowsiness and impaired concentration

Peptic ulceration history

• Use caffeine with caution

Haemorrhagic disorders

• Avoid salicylamide

Children and teenagers with chickenpox or influenza

• Aspirin has been implicated in Reye’s Syndrome, a rare but serious illness, in children and teenagers with chickenpox and influenza
• Consult a doctor before using products containing salicylamide

Hyperoxaluria patients

• Use ascorbic acid with care

Specific health conditions

• Phenylephrine should be used with caution in patients with:
  • Hyperthyroidism
  • Cardiovascular disease
  • Diabetes mellitus
  • Closed-angle glaucoma

Driving and machinery operation

• Do not drive or operate dangerous machinery after intake
• Avoid high-risk activities due to potential impaired decision-making

Sedation

• Be aware of potential sedative effects of chlorpheniramine

Forms avail. in SA and covered in this monograph: cap

South African registered indications and dosages

Relief of symptoms associated with colds and influenza such as nasal congestion, headache, minor aches and pains

Paracetamol/ Salicylamide/ Ascorbic Acid/ Caffeine/ Chlorpheniramine/ Phenylephrine
100/75/50/30/2/2 (mg)

• Oral (cap): 1-2 cap, 3 times a day after meals

Relief of cold symptoms, sinus congestion, hayfever
125/150/100/30/2/2 (mg)

• Oral (cap): 1 cap, 4hrly; Max: 6 cap/24hrs

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Do not exceed the stated dose

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Should not be used for more than 10 days without medical re-assessment

Paed. forms avail. in SA and covered in this monograph: cap

South African registered indications and dosages

Relief of symptoms associated with colds and influenza such as nasal congestion, headache, minor aches and pains

Paracetamol/ Salicylamide/ Ascorbic Acid/ Caffeine/ Chlorphenamine/ Phenylephrine
100/75/50/30/2/2 (mg)

• Younger than 6 years: Contraindicated
• Between 6-12 years: Oral (cap): 1 cap, 3 times a day after meals 
• Older than 12 years: See adult dosage

Relief of cold symptoms, sinus congestion, hayfever
125/150/100/30/2/2 (mg)

• Younger than 6 years: Not established for use
• Between 6-12 years: Oral (cap): 1 cap, twice a day
• Older than 12 years: See adult dosage

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Do not exceed the stated dose

---

Should not be used for more than 10 days without medical re-assessment

Pregnancy

South African recommendations

• Contraindicated

Breastfeeding

South African recommendations

100/75/50/30/2/2 (mg) capsule

• Caution; no information available

125/150/100/30/2/2 (mg) capsule

• Contraindicated

South African recommendations

100/75/50/30/2/2 (mg) capsule

• Caution; no information available

125/150/100/30/2/2 (mg) capsule

• Contraindicated

South African recommendations

100/75/50/30/2/2 (mg) capsule

• Mild to moderate: Caution; no dose adjustment recommended
  Caution when using other liver-affecting medicines with this combination agent
• Severe: Contraindicated

125/150/100/30/2/2 (mg) capsule

• Contraindicated

South African recommendations

• Caution; no information available

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Paracetamol
Blood and the Lymphatic System Disorders

• Thrombocytopenia
• Leucopenia
• Pancytopenia
• Agranulocytosis

Immune System Disorders

• Skin rashes
• Hypersensitivity reactions

Caffeine Anhydrous
Gastrointestinal Disorders

• Gastrointestinal irritation
• Nausea
• Vomiting
• Abdominal pain
• Diarrhoea
• Gastrointestinal bleeding

Psychiatric Disorders

• Insomnia
• Anxiety
• Restlessness

Nervous System Disorders

• Stimulation of the central nervous system
• Headache
• Dizziness
• Tremor

Cardiac Disorders

• Palpitations

Vascular Disorders

• Hypotension

Salicylamide
Immune System Disorders

• Skin rashes
• Angioedema
• Rhinitis
• Severe paroxysmal bronchospasm
• Dyspnoea

Gastrointestinal Disorders

• Nausea
• Dyspepsia
• Vomiting
• Gastric mucosa irritation
• Erosion
• Ulceration
• Haematemesis
• Melaena

Hepatobiliary Disorders

• Hepatotoxicity (especially in patients with juvenile arthritis or other connective tissue disorders)

Ascorbic Acid
Gastrointestinal Disorders

• Diarrhoea
• Gastrointestinal disturbances

Chlorphenamine
Metabolism and Nutrition Disorders

• Anorexia

Psychiatric Disorders

• Irritability
• Nightmares

Nervous System Disorders

• Sedation
• Dizziness
• Incoordination
• Tremors
• Headache

Eye Disorders

• Blurred vision

Ear and Labyrinth Disorders

• Tinnitus

Gastrointestinal Disorders

• Gastrointestinal disturbances
• Dryness of mouth

Renal and Urinary Disorders

• Difficulty in micturition

General Disorders and Administrative Site Conditions

• Tightness of chest
• Lassitude

Phenylephrine Hydrochloride
Metabolism and Nutrition Disorders

• Reduced appetite

Psychiatric Disorders

• Anxiety
• Fear
• Confusion
• Psychotic states
• Restlessness
• Insomnia

Nervous System Disorders

• Tremors
• Giddiness
• Headache

Cardiac Disorders

• Hypertension
• Ventricular dysrhythmias
• Tachycardia
• Palpitations

Gastrointestinal Disorders

• Nausea
• Vomiting
• Hypersalivation

Renal and Urinary Disorders

• Difficulty in micturition
• Urinary retention

General Disorders and Administrative Site Conditions

• Sweating

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

• Monoamine oxidase inhibitors

Chlorphenamine

• Tricyclic antidepressants
• Guanethidine
• Reserpine
• Methyldopa
• Atropine
• Central nervous system depressants
• Barbiturates
• Hypnotics
• Narcotic analgesics
• Sedatives
• Tranquillisers

Phenylephrine Hydrochloride

• Cardiac glycosides
• Quinidine
• Tricyclic antidepressants

None routine

The paracetamol/ salicylamide/ ascorbic acid/ caffeine/ chlorphenamine/ phenylephrine combination has analgesic, antihistaminic and decongestant properties.

COMBINATION PREPARATIONS

Paracetamol/ Salicylamide/ Ascorbic acid/ Caffeine/ Chlorphenamine/ Phenylephrine

Capsule 100mg/75mg/50mg/30mg/2mg/2mg

• Flutex (Pharmacare)

Capsule 125/150/100/30/2/2 (mg)

• Adco-Histamed Co (Adcock)